Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism

Phase 4

• Conditions: Subclinical Hypothyroidisms
• Interventions: Drug: Levothyroxine Sodium Tablets

• Registration Number: NCT04953195
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)

Detailed Description

In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-03
• Last Update Submitted: 2021-07-03
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Primary Completion: 2021-09-15
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men or women between the ages of 18 and 75;
• Diagnostic criteria for mild subclinical hypothyroidism :TSH>10mIU/L, thyroxine and free thyroxine levels were normal
• Positive thyroglobulin antibody and/or Thyroperoxidase antibody
• No previous use of drugs affecting thyroid function

Exclusion Criteria

• The contraindications indicated in the Chinese instructions of the drug
• Liver function impairment
• Renal function impairment
• Claustrophobia
• Mental disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levothyroxine sodium	Levothyroxine Sodium Tablets	levothyroxine sodium

Primary Outcome Measures

Name	Time	Method
Thyroid Stimulating Hormone changes	Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up	Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
free thyroxine changes	free thyroxine changes from baseline and 12 weeks during follow-up	free thyroxine changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes	Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up	Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI	T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up	T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up

Secondary Outcome Measures

Name	Time	Method
anti-thyroid peroxidase antibody changes	anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up	anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
anti-thyroglobulin antibody changes	anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up	anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up

Trial Locations

Locations (1)

Beijing Chao-Yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China